Momenta Pharmaceuticals, Inc. (MNTA)

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New article posted on MNTA's Web Site - Favorable to MNTA

Excerpts:

Gottlieb suggests sea change as administration looks to alter course of Rx drug prices

Gottlieb used his keynote address as a vanguard to an upcoming administration announcement on how it plans to alter the course of drug prices.

"As part of President Trump's bold plan to put American patients first, HHS is focused on solving a number of the problems that plague drug markets, including high list prices, seniors and government programs overpaying for drugs due to lack of negotiating tools, rising out-of-pocket costs for consumers and foreign governments free-riding off of American investment in innovation," he said.

"I can tell you that the framework the secretary has developed will dismantle many of the provisions that shield parts of the drug industry from more vigorous competition,"

Last year, Bruce Leicher, senior vice president and general counsel for Momenta Pharmaceuticals Inc. and chair of the Biosimilars Council, told a House Oversight subcommittee that the biggest barrier to competition, and lower drug prices, is innovators' abuse of REMS and self-imposed restricted distribution systems. He noted that more and more innovators were denying would-be competitors access to the reference drugs they need for bioequivalence studies and biosimilar trials.

Testifying at the same hearing, the FDA's Janet Woodcock said the agency had received more than 150 complaints from companies that have been denied samples because of REMS. Currently, all the FDA can do is inform the innovator that the intended use will not violate the REMS and refer the case to the FTC.

Another effort that's shaping up at the FDA is a biosimilar action plan, which Gottlieb said should be announced in a few weeks. Aimed at increasing competition, the plan is modeled on the drug competition action plan the agency launched last year to encourage greater generic competition.

Read more
http://www.bioworld.com/content/gottlieb-suggests-sea-change-administration-looks-alter-course-rx-drug-prices-0